Position : Complaints Management Specialist

Location : San Diego, CA

Duration : 12 Months contract

Total Hours/week : 40.00

1^st Shift

Description:

• The Specialist, Clinical Customer Advocacy is responsible for the completion of all tasks associated with complaint management and processing of event reporting, including communication for regulatory compliance with medical device reporting for both domestic and international agency regulations.

Job responsibilities, not limited to:

• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine and track product event status
• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for client products
• Write and submit complaint investigation reports into the complaint management system.
• Coordinate, research, and prepare correspondence in response to FDA and global regulatory agencies requests for additional information
• Maintain complaint in accordance with regulatory requirements.
• Comply with the site Quality System.
• Performs other duties as assigned.

Qualifications:

Education & Experience:

• Bachelor’s degree (chemistry, engineering, nursing) strongly preferred.
• 1 to 2 years’ experience in Quality, Regulatory or Complaint management is preferred. May consider equivalent combination of education and experience.

Knowledge, Skills & Abilities:

• Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry.
• Attention to detail is essential.
• Able to utilize computers for development of reports and summary of project experience.
• Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook.
• Prior work experience with Trackwise Complaint Handling System preferred.
• Prior experience filing eMDRs preferred.
• Ability to work on multiple projects with various disciplines are essential.
• Ability to multitask in an ever-changing environment.
• Position requires innovative/critical thinking, ability to solve problems and meet deadlines.
• Strong communication, organization, presentation, and writing skills.

• Complaint handling is definitely preferred, but not a deal breaker. Looking for smart, technologically adept specialists that can think critically and multi task in a constantly changing environment.